Strong Teens for Healthy Schools Change Club: A Civic Engagement Approach to Improving Physical Activity and Healthy Eating Environments

NCT05867433 | Recruiting DMC

• 2 other identifiers: IRB2022-1159DR01MD018214
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Strong Teens for Healthy Schools (STHS) is a school-based, civic engagement program that empowers middle school students to improve their physical activity and healthy eating behaviors, improve their cardiovascular disease outcomes, and create positive change in their school health environments.

Conditions

Cardiovascular Diseases; Nutrition; Physical Activity

Outcome Measures

Primary Outcomes (3)

• Presence or absence of metabolic syndrome (MetS)

  MetS is present after identifying abdominal obesity plus at least two of the four other MetS Risk factors: high blood pressure, high blood sugar, low HDL cholesterol, and high triglyceride levels. MetS = (abdominal obesity) + (2 of 4 other MetS Risk factors) Measures to determine MetS risk factors: 1. Abdominal obesity: waist circumference \>90th percentile for child's sex and age 2. High blood pressure: systolic blood pressure ≥130 mm Hg or diastolic blood pressure ≥90 mmHg) 3. High blood glucose: blood glucose ≥5.6 mmol/L or known diabetes 4. Low HDL cholesterol: HDL cholesterol \<1.03 mmol/L 5. High triglyceride level: Triglyceride level ≥ 1.7mmol/L

  Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention

• Change in the number of MetS risk factors

  Change in the number of MetS risk factors = (new # of MetS risk factors) - (original # of MetS risk factors) Measures to determine MetS risk factors: 1. Abdominal obesity: waist circumference \>90th percentile for child's sex and age 2. High blood pressure: systolic blood pressure ≥130 mm Hg or diastolic blood pressure ≥90 mmHg) 3. High blood glucose: blood glucose ≥5.6 mmol/L or known diabetes 4. Low HDL cholesterol: HDL cholesterol \<1.03 mmol/L 5. High triglyceride level: Triglyceride level ≥ 1.7mmol/L

  Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention

• Positive Youth Development score

  Positive youth development will be measured using a 5 C's Model of Positive Youth Development Scale-Short Form (PYD-SF): A 34-item scale that assesses the strength of psychological, behavioral, and social development in youth. The five dimensions measured are: 1. Competence (sense of proficiency) 2. Confidence (self-worth, self-efficacy) 3. Character (adherence to societal and cultural rules) 4. Connection (bonds with people and institutions) 5. Caring (sympathy and empathy towards others)

  Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention

Secondary Outcomes (22)

• Blood pressure level

  Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention

• Concentration of blood glucose

  Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention

• Waist circumference

  Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention

• Concentration of HDL cholesterol

  Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention

• Concentration of serum triglycerides

  Baseline, 9 months (immediate post intervention), 4 months and 12 months post intervention

Study Arms (2)

STHS Intervention

EXPERIMENTAL

Participants in this group (10 schools) will participate in the STHS program.

Behavioral: STHS Intervention

Usual Care

OTHER

Participants in this group (10 schools) will continue with usual care, as they will not be asked to add or remove any of their current, physical activity, healthy eating, or positive youth development programming.

Behavioral: Usual Care

Interventions

STHS Intervention BEHAVIORAL

STHS program The intervention group (10 schools) will participate in the STHS program. During the fall semester (September to December), the intervention group will receive 24 thirty-minute modules (or twelve 1-hour modules) that provide education on civic engagement, healthy eating, and physical activity. During the spring semester (February to May), the intervention group will receive 24 thirty-minute modules (or twelve 1-hour modules) that focus on implementing the school health environmental change project and receive support for maintaining individual-level healthy eating and physical activity behaviors.

STHS Intervention

Usual Care BEHAVIORAL

No STHS program The usual care group will be offered the same activities as the intervention group after the conclusion of the research study.

Usual Care

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 50 6th and 7th grade students
• \> 40% economically disadvantaged students
• \> 40% Black and Hispanic students

You may not qualify if:

• th or 7th grade student
• Attend a Title 1 middle school that is participating in the STHS intervention
• Read and understand English
• Participation in a weight loss program in the past 3 months
• Presence of a condition that prevents participation in physical activity

Sponsors & Collaborators

• Texas A&M University: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Texas A&M AgriLife Dallas Center

Dallas, Texas, 75252, United States

RECRUITING

Related Publications (1)

• MacMillan Uribe AL, George A, McNeely A, Xin L, Largacha Cevallos E, Rethorst C, Seguin Fowler RA, Szeszulski J. Strong Teens for Healthy Schools: Protocol for evaluating a youth nutrition, physical activity, and civic engagement protocol. Front Public Health. 2025 Sep 17;13:1654678. doi: 10.3389/fpubh.2025.1654678. eCollection 2025.

  PMID: 41041380 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Jacob S Szeszulski, PhD

CONTACT

972-231-5362; jacob.szeszulski@ag.tamu.edu

Alexandra L MacMillan Uribe, PhD

CONTACT

972-952-9275; lexi.macmillanuribe@ag.tamu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: School-based cluster randomized controlled trial

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: May 22, 2023
• Study Start: September 27, 2023
• Primary Completion (Estimated): April 15, 2027
• Study Completion (Estimated): April 15, 2027
• Last Updated: September 12, 2025

Record last verified: 2025-09

Locations

US (1)